Centralised procedure: single EU marketing authorisation via EMA

The centralised procedure is set out in Regulation (EC) No 726/2004. The applicant submits one dossier to the European Medicines Agency, the Committee for Medicinal Products for Human Use (CHMP) assesses it and adopts an opinion, and the European Commission turns that opinion into a decision that binds every Member State. Iceland, Liechtenstein and Norway adopt the decision through the EEA Agreement. The result is a single marketing authorisation number, a single set of product information in all EU languages, and one holder established in the EEA.

The Annex to the Regulation makes the route mandatory for medicines made by biotechnology, advanced therapy medicinal products, orphan medicines and new active substances for HIV, cancer, diabetes, neurodegenerative, autoimmune and viral diseases. It is optional for other new active substances, for products that are a significant innovation or in the interest of patients at Union level, and for generics of centrally authorised products. Generics of nationally authorised products stay outside it and use the decentralised or mutual recognition procedure.

In practice the work starts well before submission. Applicants request confirmation of eligibility about seven months ahead, EMA appoints a rapporteur and co-rapporteur, and a pre-submission meeting settles the timetable. After validation the assessment runs to a published schedule tied to CHMP meetings, with two clock-stops for the applicant's responses. Fees follow Regulation (EU) 2024/568, which replaced the earlier fee regulation in January 2025.

What goes wrong: assuming an optional product is eligible without asking, which costs months when the answer is no; building the submission around a desired launch date rather than the published submission deadlines and CHMP meeting dates; treating the Day 120 clock-stop as thinking time rather than a response window, so the Day 180 list of outstanding issues repeats the same major objections; and underestimating the linguistic review, when all EU language versions of the product information must be ready in the days after the opinion.

Under the new pharma package (not yet in force), the centralised procedure continues under the new Regulation, with the standard assessment time shortened and marketing authorisations valid for an unlimited period from grant; see MA validity changes.